Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00625937|
Recruitment Status : Unknown
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : February 29, 2008
Last Update Posted : February 28, 2011
RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Drug: docetaxel Drug: tegafur-gimeracil-oteracil potassium Radiation: radiation therapy||Phase 2|
- To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.
- To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.
- Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||November 2010|
- Objective response rate (complete or partial response) as assessed by RECIST criteria
- Progression-free survival
- Overall survival
- Toxicity as assessed by NCI CTCAE v3.0 criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625937
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Joo-Hang Kim, MD 82-2-2228-8131 firstname.lastname@example.org|
|Study Chair:||Joo-Hang Kim, MD||Yonsei University|